Skip to main content
OpenTrials
Completed

NCT Number: NCT01351324

A Study of Different Types of Fatty Acid on Risk Factors for Heart Disease

Experimental elevation of non-esterified fatty acids (NEFA) impairs endothelial function and insulin sensitivity but the impact of NEFA composition is unknown.

The objective was to test the effect of acute elevation of NEFA enriched with either saturated fatty acids (SFA) or SFA with long-chain n-3 polyunsaturated fatty acids (LC n-3 PUFA) on postprandial vascular function measured via flow-mediated dilatation (FMD), laser Doppler iontophoresis (LDI) and digital volume pulse (DVP), followed by a hyperinsulinaemic-euglycaemic clamp as a measure of whole body insulin sensitivity.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cardiovascular Risk Factors Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Reading

Reading, United Kingdom

About this study

To investigate potential diet-gene interactions, potential subjects (n=370) were prospectively genotyped for the eNOS Glu298Asp polymorphism, of which 35 were Asp298 and 150 were Glu298 homozygotes. Three subjects in the Asp298 group were unable to participate, two were unsuitable according to selection criteria and one subject subsequently withdrew from the study. Subjects homozygous for Asp298 (n=29) and Glu298 (n=30) were therefore selected, balanced for gender, age and BMI.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy
  • Either homozygous for eNOS Glu298 (wildtype)or eNOS Asp298 (variant)

Exclusion criteria

  • Smokers
  • Raised fasting blood lipids
  • Taking excessive fish oil supplements (>1g EPA/DHA per day)
  • Taking medication known to influence blood lipids, blood pressure or blood clotting

Treatment and study plan

Absence or presence of fish oil

Dietary Supplement

Oral dose of saturated fat with or without fish oil and a heparin infusion

Primary outcomes

  1. Flow-mediated dilatation

    Time frame: Change from baseline to 240 min

  2. Flow-mediated dilatation

    Time frame: Change from 240 min to 390 min

Secondary outcomes

  1. Digital volume pulse

    Time frame: Change from baseline to 240 min

  2. Laser Doppler iontophoresis

    Time frame: Change from baseline to 240 min

  3. Insulin sensitivity

    Time frame: 390 min

  4. NEFA composition

    Time frame: Change from baseline to 240 min

  5. Circulating endothelial function markers

    Time frame: Change from baseline to 240 min

  6. Digital volume pulse

    Time frame: Change from 240 min to 390 min

  7. Laser Doppler iontophoresis

    Time frame: Change from 240 min to 390 min

  8. Circulating endothelial markers

    Time frame: Change from 240 min to 390 min

Sponsors and collaborators

Lead sponsor

University of Reading

Other

Collaborators

  • Biotechnology and Biological Sciences Research Council
  • Foundation for Research Science and Technology (New Zealand)
  • Unilever R&D

Registry information

Official study title

Acute Elevation of Non-esterified Fatty Acids on Endothelial Function and Insulin Sensitivity: A Comparison of Saturated and Long Chain n-3 Polyunsaturated Fatty Acids During the Postprandial Phase

Acronym: eFAIRE

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
May 10, 2011
Registry last updated
May 10, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.